MRG-001 in Patients With Alcoholic Hepatitis

March 5, 2024 updated by: MedRegen LLC

An Open-Label, Dose-Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Alcoholic Hepatitis

The goal of this study is to test MRG-001 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of MRG-001 in patients with severe alcoholic hepatitis (AH).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Informed Consent: Able to provide written informed consent, either personally or through a legally acceptable representative.
  2. Male or female patients 21 years of age or older.
  3. Onset of jaundice within the prior 8 weeks.
  4. Alcohol Consumption: Average daily consumption of more than 40 grams for females or more than 60 grams for males of alcohol for 6 months or longer, with less than 8 weeks of abstinence before the onset of jaundice.

  5. Diagnostic Criteria for AH: AH may be diagnosed based on typical serum chemistry or liver biopsy during the current episode of AH, including:

    • Serum bilirubin > 3 mg/dL
    • AST between 50 and 400 IU/L
    • ALT < 400 IU/L
    • AST/ALT ratio > 1.5
  6. Maddrey Discriminant Function (MDF): MDF ≥ 32, assuming a control prothrombin time of 12 seconds.
  7. Model for End-stage Liver Disease (MELD) Score: MELD score between 21 and 30.
  8. Liver Biopsy (Optional): Liver biopsy is not required but may be used to confirm the diagnosis of AH at the Investigator's discretion. If used, the biopsy must have occurred during the current episode.
  9. Contraception for Women: Women of childbearing potential must use appropriate birth control throughout the study duration. Contraception for Men: Male patients must agree to use a medically acceptable method of contraception or birth control throughout the study duration.

Exclusion Criteria:

  1. Informed Consent: Inability to provide written informed consent, either personally or through a legally acceptable representative.
  2. Participation in Other Clinical Trials: Participation in another interventional clinical trial (drug or device) within 30 days of screening and at any time during the study.
  3. Concomitant Liver Diseases: Presence of other concomitant causes of liver disease, such as viral hepatitis, autoimmune liver disease, metabolic liver disease, or vascular liver disease.
  4. Liver Biopsy Incompatibility: Liver biopsy findings, if conducted, not compatible with alcoholic hepatitis (AH).
  5. Absence of Active Infection: No evidence of active infection as determined by the investigator, with specific criteria outlined for diagnosing and treating infections.
  6. Uncontrolled Gastrointestinal Bleeding: Presence of uncontrolled gastrointestinal bleeding.
  7. History of pre-admission refractory ascites, as defined by the frequency of paracenteses despite diuretic therapy.

  8. Significant pre-existing organ dysfunction in various systems, including lung, heart, kidney, hematologic, neurological, and spleen-related conditions.

    1. Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record.
    2. Heart: Pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record. Clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction (past 3 months), heart and coronary vessel surgery (past 3 months), significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg.
    3. Renal: End-stage renal disease requiring renal replacement therapy or creatintine clearance <30 mL/min.
    4. Hematologic: Baseline platelet count <30,000/mm3 or hemoglobin levels <6.0 g/dL.
    5. Neurological: Stage ≥3 hepatic encephalopathy by West Haven criteria.
    6. History of splenectomy or splenomegaly (spleen weighing > 750 g).
  9. Presence of any active malignancy or malignancy diagnosed within the last five years, excluding curable skin cancer.
  10. Patients requiring the use of vasopressors or inotropic support, excluding stabilized conditions within the first 7 days of hospital admission.
  11. Presence of co-infection with human immunodeficiency virus (HIV) or active tuberculosis on chest X-ray at study entry.
  12. History of organ or bone marrow transplantation, excluding corneal transplant, or recent chronic use of immunosuppressive drugs.
  13. Positive urine drug screen for specific substances, excluding THC and prescription medications.
  14. Hypersensitivity to either of the components of MRG-001.
  15. If female, known pregnancy, positive serum pregnancy test, or lactating/breastfeeding.
  16. Underlying diseases that might be complicated or exacerbated by proposed treatments or confound assessment of study drug, as determined by the site investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRG-001 (0.005 mL/kg)
Lowest dose of dose-escalation arm
Drug: MRG-001
Patients will receive subcutaneous administration of MRG-001 at designated visits.
Experimental: MRG-001 (0.007 mL/kg)
Intermediate dose of dose-escalation arm
Drug: MRG-001
Patients will receive subcutaneous administration of MRG-001 at designated visits.
Experimental: MRG-001 (0.01 mL/kg)
High dose of dose-escalation arm
Drug: MRG-001
Patients will receive subcutaneous administration of MRG-001 at designated visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Treatment-Emergent Adverse Events
Time Frame: 28 Days
Assess the safety and tolerability of MRG-001 in patients with alcoholic hepatitis (AH) as determined by the absence of suspected unexpected serious adverse reaction (SUSAR).
28 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Response
Time Frame: 28 Days
Determine the pharmacokinetics (PK) of MRG-001 in patients with AH. Trough levels (Ctrough) of plerixafor and tacrolimus will be measured throughout the study.
28 Days
Pharmacodynamic Response
Time Frame: 28 Days
The PD response will be measured by flow cytometry. The absolute number of CD34+ hematopoietic stem cells in the peripheral circulation will be assessed and compared to baseline levels.
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedRegen LLC

Investigators

  • Study Director: Ali R Ahmadi, MD PhD, MedRegen LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRG24ALC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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